Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00959192
Last Updated: 2016-01-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2009-08-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACC-001 + QS-21
Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
ACC-001
IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21
IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21
Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21
IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
Interventions
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ACC-001
IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21
IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21
IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) 16-26
Exclusion Criteria
* Major psychiatric disorder
* Clinically significant systemic illness
50 Years
85 Years
ALL
No
Sponsors
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JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, Japan
Meitetsu Hospital
Aichi, , Japan
Ibaraki Prefectural Central Hospital
Ibaraki, , Japan
Shonan Atsugi Hospital
Kanagawa, , Japan
Kitasato University East Hospital
Kanagawa, , Japan
The Jikei University School of medicine
Tokyo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, , Japan
Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
Tokyo, , Japan
Countries
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References
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Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121.
Related Links
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Other Identifiers
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B2571009
Identifier Type: OTHER
Identifier Source: secondary_id
3134K1-2206
Identifier Type: -
Identifier Source: org_study_id
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